Label: ASPIRIN NSAID- aspirin tablet
- NDC Code(s): 57896-901-01, 57896-901-10, 57896-901-27
- Packager: Geri-Care Pharmaceuticals, Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 14, 2018
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- Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*Close
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducerClose
- pain and fever of colds
- muscle pain
- minor pain of arthritis
- menstrual pain
Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
- facial swelling
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- you have asthma
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- vomit blood
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
- use by expiration date on package
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- Inactive ingredient
- Questions or comments?
- Principal Display Panel
(NSAID) • 325 mg each
PAIN RELIEVER / FEVER REDUCER
COMPARE TO THE ACTIVE
INGREDIENT OF BAYER® ASPIRIN**
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Aspirin.
GERI-CARE PHARMACEUTICAL CORP.
1650 63 Street, Brooklyn, NY 11204
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-901 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;249 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-901-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/04/1993 2 NDC:57896-901-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/04/1993 3 NDC:57896-901-27 250 in 1 BOTTLE; Type 0: Not a Combination Product 08/04/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 08/04/1993 Labeler - Geri-Care Pharmaceuticals, Corp (611196254) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(57896-901) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(57896-901) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(57896-901) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(57896-901)